An update on naltrexone/bupropion extended-release in the treatment of obesity

Expert Opinion on Pharmacotherapy

Volumn 17, Issue 16, 2016, Pages 2235-2242

  Saunders, Katherine H ^a   Igel, Leon I ^a   Aronne, Louis J ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

antiobesity medications; bupropion; Naltrexone; obesity; overweight; pharmacotherapy

Indexed keywords

AMFEBUTAMONE PLUS NALTREXONE;

ARTICLE; BEHAVIOR MODIFICATION; CARDIOVASCULAR RISK; CLINICAL TRIAL (TOPIC); DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; FEEDING BEHAVIOR; FOOD CRAVING; HUMAN; LIFESTYLE MODIFICATION; LOW CALORY DIET; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); WEIGHT REDUCTION;

EID: 84991735371     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1080/14656566.2016.1244527     Document Type: Article

References (45)

1. K.M.Flegal, D.Kruszon-Moran, M.D.Carroll, et al. Trends in obesity among adults in the United States, 2005 to 2014. JAMA. 2016;315(21):2284–2291.
2. J.W.Zylke, H.Bauchner The unrelenting challenge of obesity. JAMA. 2016;315(21):2277–2278.
3. E.A.Finkelstein, J.G.Trogdon, J.W.Cohen, et al. Annual medical spending attributable to obesity:payer-and service-specific estimates. Health Aff (Millwood). 2009;28(5):w822–31.
4. F.Magkos, G.Fraterrigo, J.Yoshino. Effects of moderate and subsequent progressive weight loss on metabolic function and adipose tissue biology in humans with obesity. Cell Metab. 2016;S1550–4131(16):30053–30055.
5. R.R.Wing, W.Lang, T.A.Wadden, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011;34(7):1481–1486.
6. W.Hinkle, M.Cordell, R.Leibel, et al. Effects of reduced weight maintenance and leptin repletion on functional connectivity of the hypothalamus in obese humans. PLoS One. 2013;8(3):e59114.
7. M.Rosenbaum, J.Hirsch, D.A.Gallagher, et al. Long-term persistence of adaptive thermogenesis in subjects who have maintained a reduced body weight. Am J Clin Nutr. 2008;88(4):906–912.
8. M.Rosenbaum, R.Goldsmith, D.Bloomfield. Low-dose leptin reverses skeletal muscle, autonomic, and neuroendocrine adaptations to maintenance of reduced weight. J Clin Invest. 2005;115(12):3579–3586.
9. M.D.Jensen, D.H.Ryan, C.M.Apovian, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults:a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014;63(25Pt B):2985–3023.•• Clinical practice guidelines for the management of adults with overweight and obesity drafted by a task force of experts from the American College of Cardiology, American Heart Association, and The Obesity Society.
10. C.M.Apovian, L.J.Aronne, D.H.Bessesen, et al. Pharmacological management of obesity:an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342–362.•• Clinical practice guidelines for the pharmacologic management of obesity drafted by an Endocrine Society-appointed task force of experts, cosponsored by the European Society of Endocrinology and The Obesity Society.
11. F.L.Greenway, M.J.Whitehouse, M.Guttadauria, et al. Rational design of a combination medication for the treatment of obesity. Obesity (Silver Spring). 2009;17(1):30–39.• The first phase II clinical trial assessing the efficacy and safety of NB compared to placebo.
12. S.K.Billes, F.L.Greenway. Combination therapy with naltrexone and bupropion for obesity. Expert Opin Pharmacother. 2011;12(11):1813–1826.
13. S.K.Billes, P.Sinnayah, M.A.Cowley. Naltrexone/bupropion for obesity:an investigational combination pharmacotherapy for weight loss. Pharmacol Res. 2014;84:1–11.
14. F.L.Greenway, E.Dunayevich, G.Tollefson, et al. Comparison of combined bupropion and naltrexone therapy for obesity with monotherapy and placebo. J Clin Endocrinol Metab. 2009;94(12):4898–4906.• The second phase II clinical trial assessing the efficacy and safety of NB compared to placebo.
15. F.L.Greenway, K.Fujioka, R.A.Plodkowski, et al. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I):a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376(9741):595–605.•• COR-I trial:phase III clinical trial assessing the efficacy and safety of NB compared to placebo.
16. C.M.Apovian, L.Aronne, D.Rubino, et al. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013;21(5):935–943.•• COR-II trial:phase III clinical trial assessing the efficacy and safety of NB compared to placebo.
17. T.A.Wadden, J.P.Foreyt, G.D.Foster, et al. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification:the COR-BMOD trial. Obesity (Silver Spring). 2011;19(1):110–120.•• COR-BMOD trial:phase III clinical trial assessing the efficacy and safety of NB combined with an intensive behavioral modification program.
18. P.Hollander, A.K.Gupta, R.Plodkowski, et al. Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. Diabetes Care. 2013;36(12):4022–4029.•• COR-Diabetes trial:phase III clinical trial assessing the efficacy and safety of NB compared to placebo in patients with type 2 diabetes.
19. K.H.Saunders, A.P.Shukla, L.I.Igel, et al. Pharmacotherapy for obesity. Endocrinol Metab Clin North Am. 2016;45(3):521–538.
20. K.H.Saunders, R.B.Kumar, L.I.Igel, et al. Pharmacologic approaches to weight management:recent gains and shortfalls in combating obesity. Curr Atheroscler Rep. 2016;18(7):36.
21. R.Khera, M.H.Murad, A.K.Chandar, et al. Association of pharmacological treatments for obesity with weight loss and adverse events:a systematic review and meta-analysis. JAMA. 2016;315(22):2424–2434.
22. L.J.Aronne, T.A.Wadden, C.Peterson, et al. Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults. Obesity (Silver Spring). 2013;21(11):2163–2171.
23. J.S.Torgerson, J.Hauptman, M.N.Boldrin, et al. XENical in the prevention of diabetes in obese subjects (XENDOS) study:a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care. 2004;27(1):155–161.
24. D.B.Allison, K.M.Gadde, W.T.Garvey, et al. Controlled-release phentermine/topiramate in severely obese adults:a randomized controlled trial (EQUIP). Obesity (Silver Spring). 2012;20(2):330–342.
25. K.M.Gadde, D.B.Allison, D.H.Ryan, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER):a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9774):1341–1352.
26. W.T.Garvey, D.H.Ryan, M.Look, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL):a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012;95(2):297–308.
27. S.R.Smith, N.J.Weissman, C.M.Anderson, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010;363(3):245–256.
28. M.C.Fidler, M.Sanchez, B.Raether, et al. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults:the BLOSSOM trial. J Clin Endocrinol Metab. 2011;96(10):3067–3077.
29. P.M.O’Neil, S.R.Smith, N.J.Weissman, et al. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus:the BLOOM-DM study. Obesity (Silver Spring). 2012;20(7):1426–1436.
30. X.Pi-Sunyer, A.Astrup, K.Fujioka, et al. A randomized, controlled trial of 3.0 mg of liraglutide in weight management. N Engl J Med. 2015;373(1):11–22.
31. M.J.Davies, R.Bergenstal, B.Bode, et al. Efficacy of liraglutide for weight loss among patients with type 2 diabetes:the SCALE diabetes randomized clinical trial. JAMA. 2015;314(7):687–699.
32. T.A.Wadden, P.Hollander, S.Klein, et al. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss:the SCALE maintenance randomized study. Int J Obes (Lond). 2013;37(11):1443–1451.
33. S.R.Smith, W.T.Garvey, F.Greenway, et al. Combination weight management (WM) pharmacotherapy with lorcaserin (LOR) and immediate release (IR) phentermine (phen) [abstract]. Poster presented at Obesity Week; 2014 Nov 2–7; Boston (MA)
34. P.A.Hollander, H.E.Bays, J.Rosenstock, et al. Coadministration of canagliflozin (CANA) and phentermine (PHEN) for weight management in overweight and obese adults. [abstract]. Poster presented at American Diabetes Association Annual Meeting; 2016 Jun 10–14, New Orleans (LA)
35. Contrave [package insert]. Deerfield (IL):Takeda Pharmaceuticals America, Inc; 2014.
36. Revia [package insert]. Pomona (CA):Duramed Pharmaceuticals, Inc; 2013.
37. Zyban [package insert]. Research Triangle Park (NC):GlaxoSmithKline; 2016.
38. A.G.Digenio, J.P.Mancuso, R.A.Gerber, et al. Comparison of methods for delivering a lifestyle modification program for obese patients:a randomized trial. Ann Intern Med. 2009 Feb;150(4):255–262.
39. T.A.Wadden, R.I.Berkowitz, L.G.Womble, et al. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med. 2005;353(20):2111–2120.
40. Cardiovascular outcomes study of naltrexone SR/bupropion SR in overweight and obese subjects with cardiovascular risk factors (the LIGHT study). ClinicalTrials.gov. 2012 [cited 2016 Jul8]. Available from:https://clinicaltrials.gov/ct2/show/NCT01601704
41. S.E.Nissen, K.E.Wolski, L.Prcela, et al. Effect of naltrexone-bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors:a randomized clinical trial. JAMA. 2016;315(10):990–1004.
42. Naltrexone/Bupropion Cardiovascular Outcomes Study ClinicalTrials.gov. 2015 [cited 2016 Jul8]. Available from:https://clinicaltrials.gov/ct2/show/NCT02638129?term=contrave+cardiovascular&rank=1
43. L.M.Stinton, E.A.Shaffer. Epidemiology of gallbladder disease:cholelithiasis and cancer. Gut Liver. 2012;6(2):172–187.
44. FDA approves weight-management drug Contrave. U.S. Food and Drug Administration. 2014 [cited 2016 July9]. Available from:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm413896.htm
45. C.E.Thomas, E.A.Mauer, A.P.Shukla, et al. Low adoption of weight loss medications:a comparison of prescribing patterns of antiobesity pharmacotherapies and SGLT2s. Obesity (Silver Spring). 2016;24(9):1955–1961.